Lyra Therapeutics (LYRA) Reports Positive Full Data Set from LANTERN Phase 2 Study of LYR-210

April 12, 2021 6:15 AM EDT

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Lyra Therapeutics, Inc. (NASDAQ: LYRA), a clinical-stage therapeutics company focused on the development and commercialization of novel integrated drug and delivery solutions for the localized treatment of patients with ear, nose and throat (ENT) diseases, today presented data from its Phase 2 LANTERN study of LYR-210, the company’s lead long-acting product candidate for chronic rhinosinusitis (CRS), at the Combined Otolaryngology Spring Meetings (COSM) 2021.

LYR-210 is an investigational product candidate designed to be administered in-office and to deliver a sustained release therapeutic for up to six months at difficult-to-access nasal inflammation sites, as a non-invasive alternative to surgery for patients who have failed medical management. Lyra reported positive topline data from the LANTERN study in December 2020.

The COSM oral presentation, titled Long-acting implantable corticosteroid matrix for chronic rhinosinusitis: Results of LANTERN Phase 2 randomized controlled study, contains the full 24-week data set from the company’s Phase 2 clinical trial of LYR-210. Previously unpublished data included: improvement from baseline in bilateral ethmoid Zinreich scores by magnetic resonance imaging (MRI); symptom improvement in both polyp and non-polyp patients; and the need for and use of rescue medication during the trial.

“The data presented today at COSM demonstrates LYR-210’s rapid and durable dose-dependent improvement based on several outcome measures, including the cardinal symptoms of CRS, SNOT-22, and MRI, in both non-polyp and polyp patients, from a single in-office administration,” said Professor Anders Cervin, Garnett Passe and Rodney Williams Memorial Foundation Chair in Otolaryngology at the University of Queensland, and a Principal Investigator for Lyra’s LANTERN trial. “Based on the results of the LANTERN trial, and my own experience with the drug candidate, I believe that LYR-210 has the potential to represent a major step forward in the care for CRS patients who are facing surgery as their next treatment option.”

Highlights from the Oral Presentation:

  • Polyp vs Non-Polyp Patients: Symptom improvement was observed in both polyp and non-polyp patients, with 100% of patients at the 7500µg dose in each group achieving the minimal clinically important difference (MCID) of 8.9 points for SNOT-22 total score by week 24, with a single administration of LYR-210.
  • Sinus Opacification: In the LANTERN study, subjects underwent paranasal sinus MRI at baseline as well as at the end of treatment. LYR-210 achieved improvement in bilateral ethmoid Zinreich scores (an objective measure of sinus opacification) at week 24 in a dose-dependent manner, providing evidence of disease modification, with the 7500µg dose achieving significant improvement compared to control between the two timepoints (p=0.031).
  • Rescue Medication: Only 1 patient in the 7500µg group and 2 patients in the 2500µg group required a rescue treatment compared to 7 patients in the control group over the 24-week treatment period. The first incidence of rescue treatment in the control group occurred at week 2, while the only patient to require rescue treatment in the 7500µg group did not require rescue treatment until after week 18. As such, LYR-210 (7500µg) reduced the need for rescue treatment (p=0.048). The need for rescue treatment in the LANTERN study was determined by the treating physician.

Separately, Lyra has shared an analysis of the LANTERN study focused on a composite of three of the cardinal symptoms of CRS.

  • Three Cardinal Symptoms: Lyra announced an analysis of a composite score of three cardinal symptoms (3CS) of CRS, which includes nasal blockage, nasal discharge and facial pain, which are the most prevalent symptoms for surgically naïve CRS patients both with and without nasal polyps. With a single administration, LYR-210 (7500µg) achieved statistically significant improvement in the 3CS composite score compared to control at week 24 (p=0.003) and at earlier timepoints.

A clinical presentation of the combined data announced today is available on Lyra’s website.

“We are delighted to present the full data set from our LANTERN study at COSM. I believe today’s data supports LYR-210’s ability to provide up to 24 weeks of effective symptom relief,” said Robert Kern, MD, Chief Medical Officer of Lyra Therapeutics. “LYR-210 is designed to provide continuous and consistent steroid treatment directly to diseased tissue and, additionally, eliminate patient compliance challenges. The additional data presented today shows that LYR-210 decreased ethmoid opacification and the need for rescue treatment in the LANTERN study, providing yet further evidence for LYR-210’s efficacy beyond the previously announced 4CS and SNOT-22 endpoints.”

“Our successful LANTERN study was designed to inform a pivotal Phase 3 trial for LYR-210, and today’s full data set has further shaped our thoughts regarding a preferred design for that trial, subject of course to an End-of-Phase 2 meeting with the FDA,” said Maria Palasis, Ph.D., President and Chief Executive Officer of Lyra Therapeutics. “In order to best address a combined polyp and non-polyp population, we are currently considering efficacy endpoints based on a composite 3CS of CRS score for our pivotal study, with the aim of bringing a much-needed new therapy to CRS patients as expeditiously as possible.”

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